Infusion device with antimicrobial properties

Abstract

The present disclosure is directed to an infusion device and method for preventing infection and microbial ingress in medical device connections. The infusion device comprising a male connector, the male connector comprising a male luer having an antimicrobial agent. In certain implementations the male luer comprises a tapered sealing member further comprising a recess containing chlorhexidine acetate.

We claim: 
     
       1. A method for delivering an antimicrobial composition into an infusion device, the method comprising:
 inserting a male connector having a male tapered surface into a female connector of the infusion device, the female connector having a female tapered surface, such that the male tapered surface engages the female tapered surface to form a substantially fluid-tight seal, the male connector having: 
 i) a distal tip having a distal end face; 
 ii) the distal tip having a recess surface proximal to the distal end face, wherein the recess surface is radially inward of a line of taper extending along, and distal of, the male tapered surface at a first taper angle relative to a central longitudinal axis of the male connector; 
 iii) a water-soluble antimicrobial composition positioned on the recess surface; 
 wherein, upon insertion of the male connector into the female connector, a cavity is formed between the recess surface and the female tapered surface, a fluid inside the infusion device at least partially fills the cavity, and at least a portion of the antimicrobial composition is dispersed within the fluid in the cavity; and 
 iv) a fluid flow channel through the male connector. 
 
     
     
       2. The method for delivering an antimicrobial composition into an infusion device of  claim 1 , the male connector further comprising a tapered surface distal edge proximal to the distal tip of the male connector, the tapered surface distal edge being at the distal most end of the male tapered surface. 
     
     
       3. The method for delivering an antimicrobial composition into an infusion device of  claim 2 , wherein the tapered surface distal edge is proximal to at least part of the recess surface in the male connector. 
     
     
       4. The method for delivering an antimicrobial composition into an infusion device of  claim 2 , wherein the tapered surface distal edge has an inner diameter, the distal tip has an outer diameter, and the inner diameter of the tapered surface distal edge is greater than the outer diameter of the distal tip. 
     
     
       5. The method for delivering an antimicrobial composition into an infusion device of  claim 2 , wherein during insertion of the male connector into the female connector the tapered surface distal edge of the male connector contacts the female tapered surface of the female connector and tapered surface edge of the male connector and both rotates and moves distally along the female tapered surface. 
     
     
       6. The method for delivering an antimicrobial composition into an infusion device of  claim 1 , wherein the male connector is a distal end portion of a needleless connector. 
     
     
       7. The method for delivering an antimicrobial composition into an infusion device of  claim 1 , wherein the antimicrobial composition comprises chlorhexidine. 
     
     
       8. The method for delivering an antimicrobial composition into an infusion device of  claim 7 , wherein a portion of the antimicrobial composition dissolves into the fluid and forms a chlorhexidine precipitate on a portion of the tapered female surface. 
     
     
       9. The method for delivering an antimicrobial composition into an infusion device of  claim 8 , wherein the chlorhexidine precipitate is formed on a portion of the tapered female surface defining the cavity between the recess surface and female tapered surface. 
     
     
       10. The method for delivering an antimicrobial composition into an infusion device of  claim 1 , wherein the distal tip of the male connector has a diameter that is less than 95 percent of a diameter of a portion of the female tapered surface radially outward of the distal tip. 
     
     
       11. The method for delivering an antimicrobial composition into an infusion device of  claim 1 , wherein the cavity defines an annular volume between the male connector and the female connector. 
     
     
       12. The method for delivering an antimicrobial composition into an infusion device of  claim 11 , wherein the annular volume is between 1 and 10 micro liters in volume. 
     
     
       13. The method for delivering an antimicrobial composition into an infusion device of  claim 1 , wherein a plurality of blades extend radially outward from the male recess surface into the cavity to at least partially divide the cavity. 
     
     
       14. The method for delivering an antimicrobial composition into an infusion device of  claim 1 , wherein the first taper angle being equal to a second taper angle of the recess surface relative to the central longitudinal axis. 
     
     
       15. The method for delivering an antimicrobial composition into an infusion device of  claim 1 , further comprising a proximal trap. 
     
     
       16. The method for delivering an antimicrobial composition into an infusion device of  claim 2 , wherein the tapered surface distal edge is proximal to at least a portion of the recess surface. 
     
     
       17. The method for delivering an antimicrobial composition into an infusion device of  claim 15 , wherein a portion of the water-soluble antimicrobial composition is contained within the proximal trap. 
     
     
       18. A method for delivering an antimicrobial composition into an infusion device, the method comprising:
 inserting a male connector having a male tapered surface into a female connector of the infusion device, the female connector having a female tapered surface, such that the male tapered surface engages the female tapered surface to form a fluid-tight seal, the male connector having: 
 i) a conical taper defined in part by the male tapered surface; 
 ii) a distal tip having an outer diameter that is less than 95 percent of an inner diameter of the female tapered surface at a point radially outward of the distal tip; 
 iii) the distal tip having a distal end face and a recess surface proximal to the distal end face of the male connector, the recess surface residing inside the conical taper; 
 iv) a tapered surface distal edge proximal to the distal end face, the tapered surface distal edge having an outer diameter greater than the outer diameter of the distal tip; 
 v) a fluid flow channel through the male connector; and 
 vi) a water-soluble antimicrobial composition positioned on the recess surface; 
 wherein upon insertion of the male connector into the female connector, an annular cavity is formed between the recess surface and the female tapered surface of the female connector, and 
 a fluid inside the infusion device at least partially fills the annular cavity, and at least a portion of the antimicrobial composition is dispersed within the fluid in the annular cavity; 
 
       wherein a proximal portion of the annular cavity is configured to collect microbes. 
     
     
       19. The method for delivering an antimicrobial composition into an infusion device of  claim 18 , wherein the annular cavity defines an annular volume between the male connector and the female connector, and wherein a portion of the antimicrobial composition dissolves into the fluid and forms a chlorhexidine precipitate on a portion of the tapered female surface. 
     
     
       20. The method for delivering an antimicrobial composition into an infusion device of  claim 18 , wherein a plurality of blades extend radially outward from the recess surface into the annular cavity to at least partially divide the annular cavity. 
     
     
       21. A method for delivering an antimicrobial composition into an infusion device, the method comprising:
 inserting a male connector having a male tapered surface into a female connector of an infusion device, the female connector having a female tapered surface, such that the male tapered surface engages the female tapered surface to form a fluid-tight seal, the male connector having: 
 i) a conical taper defined in part by the male tapered surface; 
 ii) a distal tip having an outer diameter that is less than 95 percent of an inner diameter of the female tapered surface at a point radially outward of the distal tip; 
 iii) the distal tip having a distal end face and a recess surface proximal to the distal end face and inside the conical taper; 
 iv) a tapered surface distal edge proximal to the distal tip, the tapered surface distal edge having a radius greater than a radius of the distal tip; 
 v) a fluid flow channel through the male connector; 
 vi) a water-soluble antimicrobial composition positioned on the recess surface; 
 wherein, upon insertion of the male connector into the female connector, an annular cavity is formed between the recess surface and the female tapered surface of the female connector, the annular cavity having a proximal end and a distal end, a volume between the proximal end and the distal end, a width measured radially, and a length measured axially; 
 wherein the tapered surface distal edge at least partially defines the proximal end of the annular cavity, the distal end of the annular cavity is in fluid communication with a fluid lumen of the infusion device, and the width of the annular cavity is less than 50 percent of the length of the annular cavity; and 
 wherein a fluid inside the infusion device at least partially fills the annular cavity, and at least a portion of the antimicrobial composition is dispersed within the fluid in the annular cavity. 
 
     
     
       22. The method for delivering an antimicrobial composition into an infusion device of  claim 21 , further comprising a proximal trap. 
     
     
       23. The method for delivering an antimicrobial composition into an infusion device of  claim 21 , wherein a plurality of blades extend radially outward from the recess surface into the annular cavity to at least partially divide the annular cavity. 
     
     
       24. The method for delivering an antimicrobial composition into an infusion device of  claim 21 , wherein a portion of the antimicrobial composition dissolves into the fluid and forms a chlorhexidine precipitate on a portion of the tapered female surface. 
     
     
       25. A method for delivering an antimicrobial composition into a medical tube having a female connector with a female tapered surface, the method comprising:
 inserting a male connector into the female connector such that a male tapered surface of the male connector mates with the female tapered surface, wherein the male connector includes:
 i) an end face, 
 ii) a radially-outward-facing recess surface proximal to the end face and radially inward of a line of taper extending along, and distal of, the male tapered surface at a first taper angle relative to a central longitudinal axis of the male connector, 
 iii) a fluid flow channel, and 
 iv) a water-soluble antimicrobial composition on the recess surface, wherein upon insertion of the male connector into the female connector, a cavity is defined by the recess surface and the female tapered surface; and
 upon inserting the male connector into the female connector, a fluid at least partially filling the cavity disperses at least a portion of the antimicrobial composition within the fluid in the cavity. 
 
 
 
     
     
       26. The method for delivering an antimicrobial composition into a medical tube having a female connector with a female tapered surface of  claim 25 , the male connector further comprising a tapered surface distal edge proximal to a distal end face of the male connector. 
     
     
       27. The method for delivering an antimicrobial composition into a medical tube having a female connector with a female tapered surface of  claim 26 , wherein the tapered surface distal edge is proximal to the recess surface in the male connector. 
     
     
       28. The method for delivering an antimicrobial composition into a medical tube having a female connector with a female tapered surface of  claim 25 , further comprising a proximal trap. 
     
     
       29. The method for delivering an antimicrobial composition into a medical tube having a female connector with a female tapered surface of  claim 25 , wherein a plurality of blades extend radially outward from the recess surface into the cavity to at least partially divide the cavity. 
     
     
       30. The method for delivering an antimicrobial composition into a medical tube having a female connector with a female tapered surface of  claim 25 , wherein a portion of the antimicrobial composition dissolves into the fluid and forms a chlorhexidine precipitate on a portion of the tapered female surface.